BACKGROUND: Many studies have assessed the equivalent effectiveness of tension-free vaginal tape (TVT) and transobturator suburethral tape (TVT-O) at short- to medium-term follow-up, but no long-term randomised trials appear in the literature. OBJECTIVE: We compared the use of TVT to TVT-O, providing a longer follow-up than currently appears in the literature. DESIGN, SETTING, AND PARTICIPANTS: Seventy-two consecutive patients affected by stress urinary incontinence (SUI) were included in this randomised, controlled trial. Patients were randomly allocated to the TVT or TVT-O procedure using a predetermined, computer-generated randomisation code. INTERVENTION: After preoperative assessment, patients were randomly allocated to the TVT or TVT-O procedure. MEASUREMENTS: This 5-yr study represents the extension of our original randomised trial, which was designed to assess the incidence of long-term complications (primary end point) and successes (secondary end point) for both techniques. RESULTS AND LIMITATIONS: At 60-mo follow-up, 52 patients (72%) were objectively cured of SUI (72.9% after TVT-O and 71.4% after TVT), but only 44 patients (61%) were satisfied. The late complication rate was 16.6% (10 women): five women (16.1%) in the TVT-O group and five women (17.2%) in the TVT group (p=1). In this follow-up, 62% of the patients from the TVT-O group and 60% from the TVT group (p=1) expressed that they were satisfied or very satisfied with the results. The mean cause of dissatisfaction was the development of sexual dysfunction resulting from dyspareunia or incontinence during intercourse, which was found in 6 of 16 dissatisfied patients (37.5%). The limitations of our study included the adequate but small sample size and the lack of questionnaires. CONCLUSIONS: Both surgical techniques are safe, with similar results (72.9% and 71% of patients objectively cured after TVT-O and TVT, respectively) and low complication rates (16.6%: 16.1% and 17.2%, respectively, for TVT-0 and TVT), even after 5-yr follow-up.
RCT Entities:
BACKGROUND: Many studies have assessed the equivalent effectiveness of tension-free vaginal tape (TVT) and transobturator suburethral tape (TVT-O) at short- to medium-term follow-up, but no long-term randomised trials appear in the literature. OBJECTIVE: We compared the use of TVT to TVT-O, providing a longer follow-up than currently appears in the literature. DESIGN, SETTING, AND PARTICIPANTS: Seventy-two consecutive patients affected by stress urinary incontinence (SUI) were included in this randomised, controlled trial. Patients were randomly allocated to the TVT or TVT-O procedure using a predetermined, computer-generated randomisation code. INTERVENTION: After preoperative assessment, patients were randomly allocated to the TVT or TVT-O procedure. MEASUREMENTS: This 5-yr study represents the extension of our original randomised trial, which was designed to assess the incidence of long-term complications (primary end point) and successes (secondary end point) for both techniques. RESULTS AND LIMITATIONS: At 60-mo follow-up, 52 patients (72%) were objectively cured of SUI (72.9% after TVT-O and 71.4% after TVT), but only 44 patients (61%) were satisfied. The late complication rate was 16.6% (10 women): five women (16.1%) in the TVT-O group and five women (17.2%) in the TVT group (p=1). In this follow-up, 62% of the patients from the TVT-O group and 60% from the TVT group (p=1) expressed that they were satisfied or very satisfied with the results. The mean cause of dissatisfaction was the development of sexual dysfunction resulting from dyspareunia or incontinence during intercourse, which was found in 6 of 16 dissatisfied patients (37.5%). The limitations of our study included the adequate but small sample size and the lack of questionnaires. CONCLUSIONS: Both surgical techniques are safe, with similar results (72.9% and 71% of patients objectively cured after TVT-O and TVT, respectively) and low complication rates (16.6%: 16.1% and 17.2%, respectively, for TVT-0 and TVT), even after 5-yr follow-up.
Authors: Giovanni A Tommaselli; Costantino Di Carlo; Carmen Formisano; Annamaria Fabozzi; Carmine Nappi Journal: Int Urogynecol J Date: 2015-05-20 Impact factor: 2.894
Authors: Jerry G Blaivas; Rajveer S Purohit; Matthew S Benedon; Gabriel Mekel; Michael Stern; Mubashir Billah; Kola Olugbade; Robert Bendavid; Vladimir Iakovlev Journal: Nat Rev Urol Date: 2015-08-18 Impact factor: 14.432